Contract Opportunity - Medical Device Auditors
Core
Third-party auditor evaluating medical device quality systems and technical information against ISO 13485, MDSAP, MDD, and MDR standards.
Role type
Senior IC medical device auditor
Builds
Certification recommendations and compliance verification for medical device manufacturers
Domain
Medical device regulation and quality management systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485, MDSAP, MDD, MDR, ISO 9001, non-active cardiovascular/vascular/neurovascular implants, non-active non-implantable ophthalmologic devices, general non-active non-implantable healthcare devices, sterilization technologies (EtO, Irradiation, Moist Heat), Bachelor's degree in Engineering/Bioscience/Biomedical/Science, 4+ years experience in medical device QMS
Preferred skills
Auditor credentials for ISO 13485/MDSAP/MDD/MDR, ISO 14001/ISO 45001/ISO 50001 management systems, GMP quality/regulatory experience, Spanish language proficiency
Technologies
MS Office Suite (Word, Excel, PowerPoint)
Responsibilities
Perform audits for clients' medical device quality systems and technical information, Decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue, Participate actively in witness audits by SGS or accreditation bodies, Maintain all audit credentials
Seniority
Senior, hands-on IC